Custom fitted mask and method of forming same

ABSTRACT

According to one embodiment of the invention, a method of forming a custom fitted mask includes transitioning a mask blank including a thin sheet of deformable material from a non-deformable state into a deformable state. The mask blank is applied against at least a portion of a user&#39;s face surrounding the user&#39;s nostrils while the mask blank is in the deformable state. The mask blank is deformed against the portion of the user&#39;s face to cause the mask blank to conform substantially optimally to the user&#39;s unique bone structure and facial features, the mask blank once conformed substantially optimally to the user&#39;s unique bone structure and facial features becoming the custom fitted mask. The custom fitted mask is allowed to transition from the deformable state into the non-deformable state for use.

TECHNICAL FIELD OF THE INVENTION

[0001] This invention relates generally to masks for use in medical orother clinical applications, and more particularly to a custom fittedmask and method of forming same.

BACKGROUND OF THE INVENTION

[0002] Many people experience breathing problems on a recurring basis,which often results in sleep disordered breathing (i.e. difficultysleeping, snoring, or other more serious conditions such as obstructivesleep apnea). As technology advances, people with such breathingproblems demand increased performance and comfort. Previous devices forimproving a user's breathing have included custom fitted masks that helpdeliver air or another suitable gas to the user's nose at positivepressure to help force open the user's breathing passage and thusimprove the user's breathing. However, previous masks may be relativelyexpensive due to the expertise often required to design, manufacture,and fit the masks to each particular user. Furthermore, previous maskshave often been fitted to the user's unique bone structure and facialfeatures rather poorly, if at all. As a result, previous masks haveoften failed to adequately prevent leakage from around the perimeter ofthe mask, have caused discomfort for users, and have been relativelyineffective in treating breathing problems such as sleep disorderedbreathing.

SUMMARY OF THE INVENTION

[0003] According to the present invention, problems and disadvantagesassociated with previous custom fitted masks and methods for formingthem may be reduced or eliminated.

[0004] According to one embodiment, a method of forming a custom fittedmask includes transitioning a mask blank including a thin sheet ofdeformable material from a non-deformable state into a deformable state.The mask blank is applied against at least a portion of a user's facesurrounding the user's nostrils while the mask blank is in thedeformable state. The mask blank is deformed against the portion of theuser's face to cause the mask blank to conform substantially optimallyto the user's unique bone structure and facial features, the mask blankonce conformed substantially optimally to the user's unique bonestructure and facial features becoming the custom fitted mask. Thecustom fitted mask is allowed to transition from the deformable stateinto the non-deformable state for use.

[0005] According to another embodiment, a custom fitted mask includes athin sheet of deformable material that has been formed and fitted to aportion of a user's face surrounding the user's nostrils to conformsubstantially optimally to the user's unique bone structure and facialfeatures. The portion of the user's face includes only softcartilaginous portions of the user's nose and portions of the user'sface on either side of and below the soft cartilaginous portions of theuser's nose. The portion of the user's face excludes hard bony portionsof the user's nose generally above the soft cartilaginous portions ofthe user's nose.

[0006] According to another embodiment, a mask blank for using informing a custom fitted mask includes a thin sheet of deformablematerial capable of being transitioned from a non-deformable state intoa deformable state, applied against at least a portion of a user's facesurrounding the user's nostrils while the mask blank is in thedeformable state, and deformed against the portion of the user's face tocause the mask blank to conform substantially optimally to the user'sunique bone structure and facial features. The mask blank once conformedsubstantially optimally to the user's unique bone structure and facialfeatures becomes the custom fitted mask.

[0007] Certain embodiments of the present invention may provide one ormore technical advantages. For example, in certain embodiments, a customfitted mask may be formed and fitted to a particular user relativelyquickly and easily, with little expertise required on the part of theclinical professional who is forming and fitting the mask, typicallyresulting in improved efficiency for the clinical professional andreduced cost to the user. Also in contrast to prior masks, in certainembodiments, a custom fitted mask may be formed and fitted to aparticular user so as to conform substantially optimally to the user'sunique facial structure and features. As a result, the custom fittedmask of the present invention may provide improved fit, reduced leakage,increased comfort, and better performance, whether in treating breathingproblems such as sleep disordered breathing or for any other suitablepurpose for which the custom fitted mask is used. Certain embodiments ofthe present invention may provide some, all, or more of theseadvantages. Certain embodiments may provide one or more otheradvantages, one or more of which may be readily apparent to thoseskilled in the art based on the figures, descriptions, and claimsincluded herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] For a more complete understanding of the present invention andadvantages thereof, reference is made to the following descriptionstaken in conjunction with the accompanying drawings, in which likereference numbers indicate like features and wherein:

[0009]FIG. 1 illustrates an example system for improving a user'sbreathing including a custom fitted mask;

[0010]FIG. 2 illustrates a larger view of an example custom fitted mask;

[0011]FIG. 3 illustrates an interior view of an example custom fittedmask; and

[0012]FIG. 4 illustrates an example method of forming a custom fittedmask for a particular user.

DETAILED DESCRIPTION OF THE INVENTION

[0013]FIG. 1 illustrates an example system 10 for improving a user'sbreathing including an example custom fitted mask 12. Mask 12 includes aperimeter 14 and holes 16, one for each of the user's nostrils, intowhich fittings 18 may be inserted during or after formation and fittingof mask 12. Fittings 18 may be used to couple mask 12 to an externalsystem 20, such as a continuous positive air pressure (CPAP) system, forsupplying air or another gas to the user's nose at positive pressure tohelp open the user's breathing passage and thereby improve the user'sbreathing. For example, system 10 may include tubes 22 that snap onto,are force fitted onto, or otherwise couple to fittings 18. Mask 12 mayinclude buckles or other devices 24 to couple mask 12 to one or morestraps 26, which may help secure mask 12 to the user's face during use.Devices 24 may be coupled to mask 12 during or after formation andfitting of mask 12. Although straps 26 are described as an example, mask12 being secured in any appropriate manner.

[0014] Mask 12 is preferably formed and fitted to the user's face so asto conform substantially optimally to the user's unique bone structureand facial features, including at least a portion of the user's nosesurrounding the user's nostrils. In one embodiment, mask 12 covers onlythe soft cartilaginous portions of the user's nose and portions of theuser's face to the sides of and below the soft cartilaginous portions ofthe user's nose, but does not cover the hard bony portions of the user'snose generally above the soft cartilaginous portions of the user's nose.This may allow custom fitted mask 12 to better conform to the uniqueshape of the user's face and, as a result of the improved fit, toprovide reduced leakage, increased comfort, and better performance. FIG.2 illustrates a larger view of an example mask 12, while FIG. 3illustrates an interior view of an example mask 12.

[0015] In another embodiment, as illustrated in FIG. 4, mask 12 coversat least a portion of the user's nose surrounding the user's nostrils(which may or may not be limited to the soft cartilaginous portions ofthe user's nose and portions of the user's face to the sides of andbelow the soft cartilaginous portions of the user's nose) andadditionally covers the user's mouth to prevent leakage from the user'smouth. Such a mask 12 may be formed from a single sheet of deformablematerial or may be formed from multiple sheets of deformable material(e.g., a first covering the user's nose and a second covering the user'smouth) coupled to one another using one or more screws, clips, glue, thesame or a different deformable material that is chemically bonded to thesheets of deformable material, or another appropriate fasteningtechnique. Where multiple sheets of deformable material are used, themultiple sheets may be customized for the user at the same or atdifferent times. For example, a first sheet may be customized to coverat least a portion of the user's nose at a first time and, ifappropriate, a second sheet may be customized to cover the user's mouthat a subsequent second time and then coupled to the first sheet.

[0016] In another embodiment, as illustrated in FIG. 5, mask 12 coversat least a portion of the user's nose surrounding the user's nostrils(which may or may not be limited to the soft cartilaginous portions ofthe user's nose and portions of the user's face to the sides of andbelow the soft cartilaginous portions of the user's nose), covers theuser's mouth, and additionally covers at least a portion of the user'sface below the user's chin to better secure mask 12 to the user's face.Such a mask 12 may be formed from a single sheet of deformable materialor may be formed from multiple sheets of deformable material (e.g., afirst covering the user's nose and a second covering the user's mouthand chin or a first covering the user's nose, a second covering theuser's mouth, and a third covering the user's chin) coupled to oneanother using one or more screws, clips, glue, the same or a differentdeformable material that is chemically bonded to the sheets ofdeformable material, or another appropriate fastening technique. Wheremultiple sheets of deformable material are used, the multiple sheets maybe customized for the user at the same or at different times. Forexample, a first sheet may be customized to cover at least a portion ofthe user's nose at a first time and, if appropriate, a second sheet maybe customized to cover the user's mouth and chin at a subsequent secondtime and then coupled to the first sheet.

[0017] In one embodiment, mask 12 begins as a deformable mask blank madeof a suitable deformable material. For example, a mask blank may includea suitable thermoplastic polymer and suitable fillers, stabilizers,coloring agents, antioxidants, antimicrobial agents, or other materials.As another example, a mask blank may include a light curing materialsuch as the material sold under the name TRIAD by DENTSPLY INTERNATIONALINC. Such materials are well known in various contexts to those skilledin the art.

[0018] In a more particular embodiment, a mask blank may include,possibly in addition to one or more other materials, one or more of thepolycaprolactone polymers or other aliphatic polyesters that aredescribed in U.S. Pat. Nos. 4,784,123 and 5,112,225 and productliterature of UNION CARBIDE CORPORATION. One or more polycaprolactonepolymers may have the formula:

[0019] where R is an aliphatic hydrocarbon and n may range betweenapproximately 300 to approximately 650. The TONE polycaprolactonepolymers are described in U.S. Pat. Nos. 4,784,123 and 5,112,225 andproduct literature of UNION CARBIDE CORPORATION as includinghomopolymers, block copolymers, graft copolymers, or other polymerscontaining epsilon-caprolactone. Polymerization may be initiated using adiol, for example and without limitation, ethylene glycol, diethyleneglycol, neopentyl glycol, butane diol, hexane diol, or any otherappropriate diol. The diol may have the formula:

HO—R—OH  (2)

[0020] where R is an aliphatic hydrocarbon. Where a mask blank includesone or more polycaprolactone polymers, any suitable polycaprolactonepolymer or polymers may be used. In general, polycaprolactone polymersmay display desirable dimensional stability and thermoplasticity duringcooling, biocompatibility, and a variety of other characteristics makingthem suitable for use in forming the mask blanks described herein.

[0021] In one embodiment, a mask blank may include a thin sheet ofdeformable material that is already contoured in the shape of a portionof a generic user's face, including at least the portion of the genericuser's nose surrounding the generic user's nostrils. For example, themask blank may be sized and shaped such that it will cover only the softcartilaginous portions of the generic user's nose and portions of thegeneric user's face to the sides of and below the soft cartilaginousportions of the generic user's nose, but will not cover the hard bonyportions of the generic user's nose generally above the softcartilaginous portions of the generic user's nose. In anotherembodiment, a mask blank may include a thin sheet of deformable materialthat is substantially flat except for a depression sufficient toaccommodate a generic user's nose, including at least the portion of thegeneric user's nose surrounding the user's nostrils. In anotherembodiment, a mask blank may include a thin sheet of deformable materialthat is substantially flat over its entire surface and does not includeany depressions. Thin sheets of an appropriate deformable material maybe obtained, for example, from CHESAPEAKE MEDICAL PRODUCTS, INC. In allcases, a mask blank may include pre-formed holes positioned according tothe position of a generic user's nostrils. Mask blanks may be formedusing an injection molding process (i.e. deformable material is placedinto an injection molding machine while in a liquid state), using apressing process (i.e. deformable material is placed into a press whilein a deformable state), or using any other suitable technique. Maskblanks may be sized for various classes of generic users, for example,large for men, medium for women, and small for children. In oneembodiment, mask blanks may be mass produced quickly, inexpensively, andwith high quality and uniformity. Mask blanks may include fittings 18,devices 24, or any other suitable features.

[0022] To form and fit mask 12 for a particular user using the maskblank, the mask blank is placed in a deformable state. For example,where the deformable material of the mask blank includes one or morepolycaprolactone polymers, the mask blank may be heated in a microwaveoven, in water or other non-solvent neutral liquid, or in any othersuitable manner to between approximately 140° F. and approximately 180°F. so as to place the mask blank in a deformable state. If desired,features such as fittings 18 and devices 24 may be coupled to the maskblank at this time if such features are not already coupled to the maskblank. The deformable material may chemically bond to features such asfittings 18 and devices 24 while the mask blank is in a deformable stateto produce an integral unit. While in a deformable state, the mask blankis brought in contact with the user's face, including at least a portionof the user's nose surrounding the user's nostrils. The mask blank isthen pressed against or otherwise allowed to conform to the user'sunique bone structure and facial features to form mask 12. As thedeformable material cools and hardens, mask 12 solidifies and willretain its custom fitted shape. Before or after the deformable materialsolidifies into its final custom fitted shape, mask 12 is removed fromthe user's face and is ready for use, for example, in treating sleepdisordered breathing.

[0023] As described above, mask 12 is preferably formed and fitted tothe user's face so as to conform substantially optimally to the user'sunique bone structure and facial features, including at least a portionof the user's nose surrounding the user's nostrils. In one embodiment,mask 12 covers only the soft cartilaginous portions of the user's noseand portions of the user's face to the sides of and below the softcartilaginous portions of the user's nose, but does not cover the hardbony portions of the user's nose generally above the soft cartilaginousportions of the user's nose. This may allow custom fitted mask 12 tobetter conform to the unique shape of the user's face and, as a resultof the improved fit, to provide reduced leakage, increased comfort, andbetter performance. In another embodiment, mask 12 covers at least aportion of the user's nose surrounding the user's nostrils (which may ormay not be limited to the soft cartilaginous portions of the user's noseand portions of the user's face to the sides of and below the softcartilaginous portions of the user's nose) and additionally covers theuser's mouth to prevent leakage from the user's mouth. In anotherembodiment, mask 12 covers at least a portion of the user's nosesurrounding the user's nostrils (which may or may not be limited to thesoft cartilaginous portions of the user's nose and portions of theuser's face to the sides of and below the soft cartilaginous portions ofthe user's nose), covers the user's mouth, and additionally covers atleast a portion of the user's face below the user's chin to bettersecure mask 12 to the user's face.

[0024] Although mask 12 is described primarily for use in treatingbreathing problems such as sleep disordered breathing, the presentinvention contemplates mask 12 being used or for any other suitablepurpose for which a custom fitted mask may be used. As just one example,mask 12 may be used in delivering anesthetics during surgery or anothermedical procedure.

[0025]FIG. 6 illustrates an example method of forming a custom fittedmask 12 for a particular user. The method begins at step 100, a maskblank suitable for the user is placed in a deformable state. At step102, if desired, features such as fittings 18 and devices 24 may becoupled to the mask blank if such features are not already coupled tothe mask blank. At step 104, while the mask blank is in a deformablestate, the mask blank is brought in contact with the user's face,including at least a portion of the user's nose surrounding the user'snostrils. At step 106, the mask blank is pressed against or otherwiseallowed to conform to the user's unique bone structure and facialfeatures to form mask 12. At step 108, as the deformable material coolsand hardens, mask 12 solidifies in its final custom fitted shape. Atstep 110, mask 12 is removed from the user's face and is ready for use,for example, in treating sleep disordered breathing.

[0026] Although the present invention has been described above inconnection with several example embodiments, it should be understoodthat a plethora of changes, substitutions, variations, alterations,transformations, and modifications may be suggested to one skilled inthe art, and it is intended that the present invention encompass suchchanges, substitutions, variations, alterations, transformations, andmodifications as fall within the spirit and scope of the appendedclaims.

What is claimed is:
 1. A method of forming a custom fitted mask,comprising: transitioning a mask blank comprising a thin sheet ofdeformable material from a non-deformable state into a deformable state;applying the mask blank against at least a first portion of a user'sface surrounding the user's nostrils while the mask blank is in thedeformable state; deforming the mask blank against the first portion ofthe user's face to cause the mask blank to conform substantiallyoptimally to the user's unique bone structure and facial features, themask blank once conformed substantially optimally to the user's uniquebone structure and facial features comprising the custom fitted mask;and allowing the custom fitted mask to transition from the deformablestate into the non-deformable state for use.
 2. The method of claim 1,wherein the mask blank comprises a thin sheet of deformable materialthat is already contoured in the shape of a first portion of a genericuser's face surrounding the generic user's nostrils.
 3. The method ofclaim 1, wherein the mask blank comprises a thin sheet of deformablematerial that is already contoured in the shape of a first portion of ageneric user's face surrounding the generic user's nostrils, the firstportion of the generic user's face comprising only soft cartilaginousportions of the generic user's nose and portions of the generic user'sface on either side of and below the soft cartilaginous portions of thegeneric user's nose and excluding hard bony portions of the genericuser's nose generally above the soft cartilaginous portions of thegeneric user's nose.
 4. The method of claim 1, wherein the mask blankcomprises a thin sheet of deformable material that is substantially flatexcept for a depression sufficient to accommodate at least a portion ofa generic user's nose surrounding the generic user's nostrils.
 5. Themethod of claim 1, further comprising: applying the mask blank againstat least a second portion of the user's face surrounding the user'smouth while the mask blank is in the deformable state; and deforming themask blank against the second portion of the user's face to cause themask blank to conform substantially optimally to the user's unique bonestructure and facial features, the mask blank once conformedsubstantially optimally to the user's unique bone structure and facialfeatures comprising the custom fitted mask.
 6. The method of claim 5,wherein: the mask blank comprises a first portion for applying to thefirst portion of the user's face and a second portion for applying tothe second portion of the user's face; and the method further comprisescoupling the first portion of the mask blank to the second portion ofthe mask blank in forming the custom fitted mask.
 7. The method of claim5, further comprising: applying the mask blank against at least a thirdportion of the user's face under the user's chin while the mask blank isin the deformable state; and deforming the mask blank against the thirdportion of the user's face to cause the mask blank to conformsubstantially optimally to the user's unique bone structure and facialfeatures, the mask blank once conformed substantially optimally to theuser's unique bone structure and facial features comprising the customfitted mask.
 8. The method of claim 7, wherein: the mask blank comprisesa first portion for applying to the first portion of the user's face anda second portion for applying to the second and third portions of theuser's face; and the method further comprises coupling the first portionof the mask blank to the second portion of the mask blank in forming thecustom fitted mask.
 9. The method of claim 1, wherein the mask blankcomprises an injection molded mask blank.
 10. The method of claim 1,wherein the mask blank comprises holes, one for each of the user'snostrils, into which fittings have been inserted for coupling the customfitted mask to an external gas supply system.
 11. The method of claim 1,wherein the mask blank comprises holes for receiving devices forcoupling the custom fitted mask to one or more straps for securing thecustom fitted mask to the user's face.
 12. The method of claim 1,wherein the deformable material comprises a thermoplastic polymer andthe mask blank is heated to transition the mask blank into thedeformable state.
 13. The method of claim 12, wherein the thermoplasticpolymer comprises a polycaprolactone polymer.
 14. The method of claim 1,wherein the custom fitted mask when in use covers a portion of theuser's face surrounding the user's nostrils, the portion of the user'sface comprising only soft cartilaginous portions of the user's nose andportions of the user's face on either side of and below the softcartilaginous portions of the user's nose but does not cover hard bonyportions of the user's nose generally above the soft cartilaginousportions of the user's nose.
 15. The method of claim 1, wherein thecustom fitted mask comprises a mask for use in treating sleep disorderedbreathing.
 16. A custom fitted mask, comprising a first thin sheet ofdeformable material that has been formed and fitted to a first portionof a user's face surrounding the user's nostrils to conformsubstantially optimally to the user's unique bone structure and facialfeatures, the first portion of the user's face comprising only softcartilaginous portions of the user's nose and portions of the user'sface on either side of and below the soft cartilaginous portions of theuser's nose, the first portion of the user's face excluding hard bonyportions of the user's nose generally above the soft cartilaginousportions of the user's nose.
 17. The mask of claim 16, wherein the firstthin sheet of deformable material has been additionally formed andfitted to a second portion of the user's face surrounding the user'smouth to conform substantially optimally to the user's unique bonestructure and facial features.
 18. The mask of claim 17, wherein thefirst thin sheet of deformable material has been additionally formed andfitted to a third portion of the user's face under the user's chin toconform substantially optimally to the user's unique bone structure andfacial features.
 19. The mask of claim 16, further comprising: a secondthin sheet of deformable material has been formed and fitted to a secondportion of the user's face surrounding the user's mouth to conformsubstantially optimally to the user's unique bone structure and facialfeatures; and one or more fastening agents coupling the first thin sheetof deformable material to the second thin sheet of deformable material.20. The mask of claim 19, wherein the second thin sheet of deformablematerial has been additionally formed and fitted to a third portion ofthe user's face under the user's chin to conform substantially optimallyto the user's unique bone structure and facial features.
 21. The mask ofclaim 16, wherein the custom fitted mask comprises holes, one for eachof the user's nostrils, into which fittings have been inserted forcoupling the custom fitted mask to an external gas supply system. 22.The mask of claim 16, wherein the custom fitted mask comprises devicesfor coupling the custom fitted mask to one or more straps for securingthe custom fitted mask to the user's face.
 23. The mask of claim 16,wherein the deformable material comprises a thermoplastic polymer andthe custom fitted mask must be heated to place the deformable materialinto a deformable state.
 24. The method of claim 23, wherein thethermoplastic polymer comprises a polycaprolactone polymer.
 25. Themethod of claim 26, wherein the custom fitted mask comprises a mask foruse in treating sleep disordered breathing.
 26. A mask blank for usingin forming a custom fitted mask, comprising a thin sheet of deformablematerial capable of being: transitioned from a non-deformable state intoa deformable state; applied against at least a first portion of a user'sface surrounding the user's nostrils while the mask blank is in thedeformable state; and deformed against the first portion of the user'sface to cause the mask blank to conform substantially optimally to theuser's unique bone structure and facial features, the mask blank onceconformed substantially optimally to the user's unique bone structureand facial features comprising the custom fitted mask.
 27. The maskblank of claim 26, wherein: the thin sheet of deformable material iscontoured in the shape of at least a first portion of a generic user'sface surrounding the generic user's nostrils; and the thin sheet ofdeformable material is capable of being deformed against at least thefirst portion of the user's face surrounding the user's nostrils. 28.The mask blank of claim 26, wherein: the thin sheet of deformablematerial is contoured in the shape of a first portion of a genericuser's face surrounding the generic user's nostrils, the first portionof the generic user's face comprising only soft cartilaginous portionsof the generic user's nose and portions of the generic user's face oneither side of and below the soft cartilaginous portions of the genericuser's nose and excluding hard bony portions of the generic user's nosegenerally above the soft cartilaginous portions of the generic user'snose; and the thin sheet of deformable material is capable of beingdeformed against a first portion of the user's face surrounding theuser's nostrils, the first portion of the user's face comprising onlysoft cartilaginous portions of the user's nose and portions of theuser's face on either side of and below the soft cartilaginous portionsof the user's nose and excluding hard bony portions of the user's nosegenerally above the soft cartilaginous portions of the user's nose. 29.The mask blank of claim 26, wherein: the thin sheet of deformablematerial is substantially flat except for a depression sufficient toaccommodate at least a portion of a generic user's nose surrounding thegeneric user's nostrils; and the thin sheet of deformable material iscapable of being deformed against at least a first portion of the user'sface surrounding the user's nostrils.
 30. The mask blank of claim 26,further capable of being: applied against at least a second portion ofthe user's face surrounding the user's mouth while the mask blank is inthe deformable state; and deformed against the second portion of theuser's face to cause the mask blank to conform substantially optimallyto the user's unique bone structure and facial features, the mask blankonce conformed substantially optimally to the user's unique bonestructure and facial features comprising the custom fitted mask.
 31. Themask blank of claim 30, wherein the mask blank comprises a first portionfor applying to the first portion of the user's face and a secondportion for applying to the second portion of the user's face, the firstportion of the mask blank capable of being coupled to the second portionof the mask blank in forming the custom fitted mask.
 32. The mask blankof claim 30, further capable of being: applied against at least a thirdportion of the user's face under the user's chin while the mask blank isin the deformable state; and deformed against the third portion of theuser's face to cause the mask blank to conform substantially optimallyto the user's unique bone structure and facial features, the mask blankonce conformed substantially optimally to the user's unique bonestructure and facial features comprising the custom fitted mask.
 33. Themask blank of claim 32, wherein the mask blank comprises a first portionfor applying to the first portion of the user's face and a secondportion for applying to the second and third portions of the user'sface, the first portion of the mask blank capable of being coupled tothe second portion of the mask blank in forming the custom fitted mask.34. The mask blank of claim 26, wherein the mask blank comprises aninjection molded mask blank.
 35. The mask blank of claim 26, furthercomprising holes, one for each of the generic user's nostrils, intowhich fittings may be inserted for coupling the custom fitted mask to anexternal gas supply system.
 36. The mask blank of claim 26, wherein themask blank comprises holes for receiving devices for coupling the customfitted mask to one or more straps for securing the custom fitted mask tothe user's face.
 37. The mask blank of claim 26, wherein the deformablematerial comprises a thermoplastic polymer and the mask blank must beheated to transition the mask blank into the deformable state.
 38. Themask blank of claim 37, wherein the thermoplastic polymer comprises apolycaprolactone polymer.
 39. The mask blank of claim 26, wherein thecustom fitted mask when in use covers a portion of the user's facesurrounding the user's nostrils, the portion of the user's facecomprising only soft cartilaginous portions of the user's nose andportions of the user's face on either side of and below the softcartilaginous portions of the user's nose but does not cover hard bonyportions of the user's nose generally above the soft cartilaginousportions of the user's nose.
 40. The mask blank of claim 26, wherein thecustom fitted mask comprises a mask for use in treating sleep disorderedbreathing.
 41. A method of forming a custom fitted mask, comprising:accessing a mask blank comprising a thin sheet of deformablethermoplastic polymer material that is already contoured in the shape ofa portion of a generic user's face surrounding the generic user'snostrils, the portion of the generic user's face comprising only softcartilaginous portions of the generic user's nose and portions of thegeneric user's face on either side of and below the soft cartilaginousportions of the generic user's nose and excluding hard bony portions ofthe generic user's nose generally above the soft cartilaginous portionsof the generic user's nose; inserting into holes of the mask blank, onefor each of a user's nostrils, fittings for coupling the custom fittedmask to an external gas supply system; heating the mask blank totransition the mask blank from a non-deformable state into a deformablestate; while the mask blank is in the deformable state, applying themask blank against a portion of the user's face surrounding the user'snostrils, the portion of the user's face comprising only softcartilaginous portions of the user's nose and portions of the user'sface on either side of and below the soft cartilaginous portions of theuser's nose and excluding hard bony portions of the user's nosegenerally above the soft cartilaginous portions of the user's nose;deforming the mask blank against the portion of the user's face to causethe mask blank to conform substantially optimally to the user's uniquebone structure and facial features, the mask blank once conformedsubstantially optimally to the user's unique bone structure and facialfeatures comprising the custom fitted mask; and allowing the customfitted mask to transition from the deformable state into thenon-deformable state for use in treating sleep disordered breathing, thecustom fitted mask when in use covering a portion of the user's facesurrounding the user's nostrils, the portion of the user's facecomprising only soft cartilaginous portions of the user's nose andportions of the user's face on either side of and below the softcartilaginous portions of the user's nose and excluding hard bonyportions of the user's nose generally above the soft cartilaginousportions of the user's nose.
 42. A mask blank for using in forming acustom fitted mask for treating sleep disordered breathing, the maskblank comprising a thin sheet of deformable thermoplastic polymermaterial contoured in the shape of a portion of a generic user's facesurrounding the generic user's nostrils, the portion of the genericuser's face comprising only soft cartilaginous portions of the genericuser's nose and portions of the generic user's face on either side ofand below the soft cartilaginous portions of the generic user's nose andexcluding hard bony portions of the generic user's nose generally abovethe soft cartilaginous portions of the generic user's nose, the thinsheet of deformable thermoplastic polymer material comprising holes, onefor each of a user's nostrils, into which fittings may be inserted forcoupling the custom fitted mask to an external gas supply system, thethin sheet of deformable thermoplastic polymer material capable ofbeing: heated to transition the mask blank from a non-deformable stateinto a deformable state; applied against at least a portion of theuser's face surrounding the user's nostrils while the mask blank is inthe deformable state, the portion of the user's face comprising onlysoft cartilaginous portions of the user's nose and portions of theuser's face on either side of and below the soft cartilaginous portionsof the user's nose and excluding hard bony portions of the user's nosegenerally above the soft cartilaginous portions of the user's nose; anddeformed against the portion of the user's face to cause the mask blankto conform substantially optimally to the user's unique bone structureand facial features, the mask blank once conformed substantiallyoptimally to the user's unique bone structure and facial featurescomprising the custom fitted mask.